Hercules Suture Anchor System

GUDID 00810021860237

Hercules™ FT Suture Anchor, 4.5 mm x 13.5 mm with two #2 BightForce Suture and tapered 1/2 circle needles

IN2BONES USA, LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00810021860237
NIH Device Record Key067a2138-eb45-4b18-9def-bdfd927a18ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameHercules Suture Anchor System
Version Model NumberA20 SP245
Company DUNS079700711
Company NameIN2BONES USA, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810021860237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-22
Device Publish Date2020-12-14

On-Brand Devices [Hercules Suture Anchor System]

00810021860244Hercules™ FT Suture Anchor, 5.5 mm x 16.5 mm with two #2 BightForce Suture and tapered 1/2 ci
00810021860237Hercules™ FT Suture Anchor, 4.5 mm x 13.5 mm with two #2 BightForce Suture and tapered 1/2 ci
00810021860220Hercules™ FT Suture Anchor, 3.5 mm x 10.5 mm with two #0 BightForce Suture and tapered 1/2 ci
00810021860213Hercules™ FT Suture Anchor, 2.5 mm x 7.5 mm with two 2-0 BightForce Suture and tapered 1/2 ci
00810021860206Hercules™ FT Suture Anchor, 2.0 mm x 6.5 mm with two 3-0 BightForce Suture and tapered 1/2 ci
00810021860190Hercules™ Knotless Anchor, 5.5 mm x 19.5 mm
00810021860183Hercules™ Knotless Anchor, 4.5 mm x 15.5 mm
00810021860176Hercules™ Knotless Suture Anchor, 3.5 mm x 12 mm
00810021860169Hercules™ Knotless Suture Anchor, 2.5 mm x 8.6 mm

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